Losartan - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 58,600 mg; cellulose microcrystalline - 20,000 mg; croscarmellose sodium - 4,000 mg; povidoy (polyvinylpyrrolidone low molecular weight) - 3,200 mg; silicon dioxide colloidal -0,700 mg; magnesium stearate - 1,000 mg;

Film Sheath: [hypromellose - 1,800 mg, talc 0,600 mg, titanium dioxide -0,330 mg, macrogol 4000 (polyethylene glycol 4000) - 0.270 mg] or [dry mixture for film coating containing hypromellose (60%), talc (20%), titanium dioxide (11%), macrogol 4000 (polyethylene glycol 4000) (9%)] - 3,000 mg.

Dosage of 25 mg

active substance: losartan potassium - 25,000 mg;

Excipients: lactose monohydrate - 117,200 mg; microcrystalline cellulose - 40,000 mg;croscarmellose sodium - 8,000 mg; povidone (low molecular weight polyvinylpyrrolidone) - 6,400 mg; silicon dioxide colloidal - 1,400 mg; magnesium stearate - 2,000 mg;

film sheath: [hypromellose - 3,600 mg, talc - 1,200 mg, titanium dioxide -0,620 mg, macrogol 4000 (polyethylene glycol 4000) - 0.540 mg, iron oxide yellow (iron oxide) - 0.040 mg] or [dry film coating mixture containing hypromellose (60 %), talc (20%), titanium dioxide (10.33%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide yellow (iron oxide) (0.67%) - 6,000 mg.

Dosage 50 mg

active substance: Losartan potassium - 50,000 mg;

Excipients: lactose monohydrate - 57,500 mg; cellulose microcrystalline - 20,000 mg; croscarmellose sodium - 5,600 mg; povidone (polyvinylpyrrolidone low molecular weight) - 4,500 mg; silicon colloidal dioxide -1,000 mg; magnesium stearate - 1,400 mg;

film sheath: [hypromellose - 2,400 mg, talc - 0,800 mg, titanium dioxide -0,440 mg, macrogol 4000 (polyethylene glycol 4000) - 0.360 mg] or [dry mixture for film coating containing hypromellose (60%). talc (20%), titanium dioxide (11%), macrogol 4000 (polyethylene glycol 4000) (9%)] - 4,000 mg.

Dosage of 100 mg

active substance: losartan potassium - 100,000 mg;

Excipients: lactose monohydrate - 115,000 mg; microcrystalline cellulose - 40,000 mg; croscarmellose sodium - 11,200mg; povidone (polyvinylpyrrolidone low molecular weight) - 9,000 mg; silicon dioxide colloid -2,000 mg; magnesium stearate - 2,800 mg;

film sheath: [hypromellose 4,800 mg, talc 1,600 mg, titanium dioxide -0,826 mg, macrogol 4000 (polyethylene glycol 4000) 0.720 mg, iron oxide yellow (iron oxide) 0.054 mg] or [dry film-coating mixture containing hypromellose (60 %), talc (20%), titanium dioxide (10.33%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide yellow (iron oxide) (0.67%)] - 8,000 mg.

Description:Round biconvex tablets coated with a white or almost white film coating (doses of 12.5 mg and 50 mg) or yellow (dosages of 25 mg and 100 mg). On the cross section, the nucleus is white or almost white in color.

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.01 Losartan

C.09.C.A Angiotensin II antagonists

Pharmacodynamics:

Losartan is a specific antagonist of angiotensin II receptors (type AT₁) for oral administration. Angiotensin II selectively binds to AT₁receptors found in many tissues (in the smooth muscle tissues of blood vessels, in the adrenal glands, in the nights and in the heart) and performs several important biological functions, including vasoconstriction and aldosterone release. Angiotensin II also stimulates proliferation of smooth muscle cells.

Losartan and its pharmacologically active metabolite (E 3174) both in vitro and in vivo block all the physiological effects of angiotensin II, regardless of the source or route of synthesis. Losartan selectively binds to the AT₁-receptors; does not bind or block receptors of other hormones and ion channels, which play an important role in regulating the functions of the cardiovascular system. Besides, losartan does not inhibit angiotensin-converting enzyme (AIF), which promotes degradation of bradykinin. therefore, side effects mediated by bradykinin (eg, angioedema) are rare.

When losartan is used, the absence of negative feedback influence the secretion of renin leads to an increase in renin plasma activity. Increased renin activity leads to an increase in the concentration of angiotensin II in blood plasma. However, antihypertensive activity and a decrease in plasma aldosterone concentration persist, indicating an effective blockade of angiotensin II receptors. After abolition of losartan, the plasma renin activity and angiotensin II concentration decreased for 3 days to the initial values observed before the drug was started.

Losartan and its active metabolite have a great affinity for the receptors of angiotensin II (type AT₁).

The concentration of losartan and its active metabolite in the blood plasma, as well as the antihypertensive effect of losartan increase with increasing dose of the drug. The maximum antihypertensive effect develops in 3-6 weeks after the start of the drug.

In patients with arterial hypertension, proteinuria (more than 2 g per day), without diabetes mellitus, the use of the drug significantly reduces proteinuria, albumin excretion and immunoglobulin G (IgG).

In postmenopausal women with hypertension, who took losartan in a dose of 50 mg per day for 4 weeks, there was no effect of therapy on the renal and systemic levels of prostaglandins.

Losartan does not affect vegetative reflexes and does not have a lasting effect on the level of norepinephrine in the blood plasma.

In patients with hypertension losartan in doses up to 150 mg per day does not cause clinically significant changes in the concentration of triglycerides, total cholesterol and high-density lipoprotein cholesterol. In the same doses losartan does not affect the concentration of glucose in the blood on an empty stomach. Losartan caused a decrease in the plasma concentration of uric acid (usually less than 0.4 mg / dl), which persisted during prolonged therapy. In controlled clinical trials involving patients with hypertension, there were no cases of drug withdrawal due to an increase in creatinine or potassium in the blood plasma.

Pharmacokinetics:

Suction

Ingestion losartan well absorbed from the gastrointestinal tract. Systemic bioavailability of losartan is approximately 33%, food intake does not affect the bioavailability of losartan. The average maximum concentrations of losartan and its active metabolite are reached after 1 hour and after 3-4 hours, respectively.

Distribution

Lozartan and its active metabolite bind to plasma proteins (mainly albumin) by more than 99%. The volume of distribution of losartan is 34 liters. Losartan practically does not penetrate the blood-brain barrier.

Metabolism

Losartan is subjected to the effect of "primary passage" through the liver, is metabolized with the participation of the cytochrome P450 isoenzyme CYP2C9.Approximately 14% of the dose of losartan administered intravenously orally is converted to its active metabolite (EXP 3 174) with the carboxyl group. Biologically inactive metabolites are also formed: the two major (as a result of the hydroxylation of the butyl side chain) and the less significant N-2-tetrazole-glucuronide.

Excretion

The plasma clearance of losartan and its active metabolite is 600 ml / min and 50 ml / min, respectively. The renal clearance of losartan and its active metabolite is approximately 74 ml / min and 26 ml / min, respectively.

When taking losartan, about 4% of the dose is excreted unchanged by the kidneys and within 6% of the dose is excreted by the kidneys as an active metabolite. Losartan and its active metabolite have linear pharmacokinetics when administered to losartan in doses up to 200 mg. After oral administration, the plasma concentrations of losartan and its active metabolite decrease nonexponentially with finite T_1/2 (half-life) approximately 2 hours and 6-9 hours, respectively.

The excretion of losartan and its metabolites occurs with bile and kidneys. After ingestion of losartan, labeled¹⁴C, about 35% of the radioactive label is found in urine and 58% in feces.

Pharmacokinetics in specific patient groups

Elderly patients

The concentrations of losartan and its active metabolite in blood plasma in elderly male patients with arterial hypertension significantly differ from these indices in younger male patients with hypertension.

Floor

Concentrations of losartan in blood plasma were 2 times higher in women with arterial hypertension compared with men with arterial hypertension. The concentrations of active metabolite in men and women did not differ. This apparent pharmacokinetic difference is not clinically significant.

Patients with hepatic impairment

When losartan was administered orally in patients with cirrhosis of the alcoholic liver of mild to moderate severity, the concentrations of losartan and its active metabolite in blood plasma were higher by 5 and 1.7 times, respectively, than in young healthy male volunteers.

Patients with impaired renal function

Concentrations of losartan in blood plasma in patients with creatinine clearance above 10 ml / min did not differ from those in patients with normal renal function. In patients requiring hemodialysis, the area under the concentration-time curve (AUC) is approximately 2 times greater than in patients with normal renal function.Plasma concentrations of active metabolite but vary in patients with impaired renal function or in patients on hemodialysis. Losartan and its active metabolite are not removed from the bloodstream by hemodialysis.

Indications:

- Arterial hypertension;

- reduction in the risk of associated cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy, manifested by a decrease in the total incidence of cardiovascular mortality, stroke and myocardial infarction;

- kidney protection in patients with type 2 diabetes mellitus with proteinuria - slowing the progression of renal failure, manifested by a decrease in the frequency of hypercrossiaemia, the frequency of the terminal stage of chronic renal failure (CRF) requiring hemodialysis or kidney transplantation, mortality rates, and a decrease in proteinuria;

- Chronic heart failure (CHF) with ineffective treatment with ACE inhibitors or intolerance to ACE inhibitors.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- Pregnancy;

- the period of breastfeeding;

- age up to 18 years;

- refractory hyperkalemia;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;

- dehydration;

- severe hepatic insufficiency (more than 9 points on the Child-Pyo scale) (no experience of application);

- simultaneous use with aliskiren or aliskirenoderzhaschimi drugs in patients with diabetes mellitus and / or with impaired renal function (glomerular filtration rate less than 60 ml / min / 1.73 m²).

Carefully:

- angioedema in history;

- arterial hypotension;

- reduced volume of circulating blood (BCC);

- Violation of the water-electrolyte balance;

- primary hyperaldosteronism;

- Hyperkalemia;

- Liver failure (less than 9 on the Child-Pyo scale);

- kidney failure;

- conditions after kidney transplantation;

- bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;

- aortic and mitral stenosis; hypertrophic obstructive cardiomyopathy;

- severe heart failure (IV functional class according to the NYIIA classification);

- cardiac ischemia;

- heart failure with life-threatening arrhythmias;

- heart failure with concomitant severe renal insufficiency;

- cerebrovascular diseases.

Pregnancy and lactation:

Pregnancy

Application of the drug Losartan when pregnancy is contraindicated.

Drugs that directly affect the renin-angiotensin-aldosterone system (PAL), when used in the second and third trimesters of pregnancy, can cause a developmental defect or even the death of a developing fetus. Therefore, when diagnosing a pregnancy, taking the drug Losartan should be immediately discontinued and, if necessary, an alternative antihypertensive therapy is prescribed for drugs that have an established safety profile when applied during pregnancy.

In experimental studies, it is shown that the drug causes developmental defects and leads to the death of the fetus or newborn. It is believed that the mechanism of such an effect is a pharmacologically mediated effect on RAAS.

Renal perfusion of a human fetus, depending on the development of RAAS, begins in the second trimester. The risk to the fetus increases if the drug Losartan take in the II or III trimester of pregnancy. The use of angiotensin II receptor antagonists in the II or III trimesters of pregnancy has a toxic effect on the fetus (decreased kidney function, development of oligohydramnion, slowing ossification of the skull) and newborn (renal failure, arterial hypotension, hyperkalemia). If the drug Losartan was used in the second trimester of pregnancy and later, it is recommended to perform an ultrasound examination of the skull bones and assess the kidney function, if it is impossible to select an alternative therapy in exchange for drugs that affect RAAS, it is necessary to inform the patient about the possible risk of therapy for the fetus. It is necessary to conduct periodic ultrasound examinations to assess the intra-amniotic space. Depending on the week of pregnancy, it is necessary to conduct appropriate tests of the lode.

If the newborns whose mothers took the drug Losartan during pregnancy, there is a development of oliguria or arterial hypotension, it is necessary to carry out symptomatic therapy aimed at maintaining blood pressure (BP) of renal perfusion.You may need a blood transfusion or hemodialysis to prevent the development of arterial hypotension and / or kidney function.

Breastfeeding period

It is not known whether losartan with breast milk. When using the drug Losartan during breastfeeding should decide whether to stop breastfeeding, or to stop treatment with the drug, taking into account its importance for the mother.

Dosing and Administration:

Inside, regardless of the time of ingestion, without chewing, washing with a small amount of water.

A drug Losartan can be taken as in monotherapy, or in combination with other antihypertensive drugs.

Arterial hypertension

The standard initial and maintenance dose for most patients is 50 mg once daily. The maximum antihypertensive effect is achieved 3-5 weeks after the start of therapy.

In some patients, to achieve a greater effect, the dose may be increased to a maximum daily dose of 100 mg once daily.

In patients with reduced BCC (for example, when taking diuretics in high doses) the initial dose of the drug should be reduced to 25 mg once a day (see section "Special instructions").

There is no need to select an initial dose in elderly patients and in patients with renal insufficiency, including patients not in hemodialysis.

Patients with hepatic insufficiency (less than 9 on the Child-Pugh scale) are recommended to prescribe the drug Losartan in a lower initial dose of 25 mg once a day.

Reduced risk of associated cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy

The standard initial dose of the drug Losartan is 50 mg once daily. It is recommended to add hydrochlorothiazide in a low dose or increase the dose of the drug Losartan up to 100 mg (taking into account the degree of BP reduction) in one or two doses.

Kidney protection in patients with type 2 diabetes and proteinuria

The standard initial dose of the drug is 50 mg once a day. Further it is recommended to increase the dose of the drug Losartan up to 100 mg once a day, taking into account the degree of decrease in blood pressure. A drug Losartan can be appointed together with other antihypertensive drugs (diuretics, blockers of "slow" calcium channels,alpha and beta-address blockers, antihypertensive drugs of central action), insulin and other hypoglycemic drugs (derivatives of sulfonylurea, glitazones and glucosidase inhibitors).

CHF

The initial dose of the drug is 12.5 mg once a day. Typically, the dose is selected at a weekly interval (i.e., the first week is 12.5 mg once a day, the second week is 25 mg once a day, then 50 mg once a day) to a normal maintenance dose of 50 mg alone once a day, depending on individual tolerability. The maximum daily dose is 150 mg once a day (only for this indication).

Side effects:

In most cases losartan well tolerated, side effects are mild and transient and do not require withdrawal of the drug.

Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO): very often> 1/10;

often from> 1/100 to <1/10;

infrequently from> 1/1000 to <1/100;

rarely from> 1/10000 to <1/1000;

very rarely <1/10000, including individual messages;

the frequency is unknown - according to available data, it is possible to establish the frequency of occurrence.

From the nervous system:

often - dizziness, loss of consciousness;

infrequently - drowsiness, headache, sleep disturbances, paresthesia, hyposthenia, memory disorder, peripheral neuropathy, tremor, ataxia;

frequency is unknown - migraine, depression.

From the sense organs:

often - vertigo, ringing in the ears;

infrequently - a violation of visual acuity, conjunctivitis, a violation of taste sensations.

From the cardiovascular system:

often - tachycardia, bradycardia;

infrequently - orthostatic hypotension (dose-dependent), palpitations, angina pectoris;

rarely - a syncope, a ciliary arrhythmia, an acute infringement of a cerebral circulation.

From the respiratory system:

often - cough, infections of the upper respiratory tract (pharyngitis, rhinitis, sinusitis, bronchitis), edema of the nasal mucosa; often - dyspnoea.

From the digestive system:

often - diarrhea, nausea, dyspeptic disorders;

infrequently - abdominal pain, constipation, vomiting, flatulence, gastritis, anorexia;

rarely - hepatitis;

the frequency is unknown - pancreatitis, liver function disorders.

From the genitourinary system:

often - renal failure, impaired renal function;

infrequently - urinary tract infections, mandatory urges to urinate;

frequency is unknown - erectile dysfunction.

From the musculoskeletal system:

often - cramps in the muscles of the lower extremities, pain in the back, chest, legs;

infrequently - myalgia, arthralgia, arthritis, rhabdomyolysis.

From the skin:

often - urticaria, skin rash, itching, dry skin, erythema, increased diarrhea, alopecia, photosensitivity. Allergic reactions:

rarely - anaphylactic reactions, angioedema, including face, lips, pharynx and / or tongue, allergic vasculitis, including purple Shenlen Genoch.

From the hematopoiesis:

often anemia, thrombocytopenia.

Laboratory indicators:

often - hyperkalemia, increased concentration of urea and creatinine in the blood, hypoglycemia;

rarely - increased activity of "liver" transaminases;

very rarely - hyperbilirubinemia;

frequency is unknown - hyponatremia.

Other:

often - asthenia, increased fatigue, swelling, a feeling of palpitation, a feeling of general discomfort.

Attention! If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose:

Svedeniya about an overdose of a preparation are limited.

The most likely symptoms

Pronounced decrease in blood pressure and tachycardia; Bradycardia can occur due to parasympathetic (vagal) stimulation.

Treatment

Forced diuresis, symptomatic therapy.

Neither losartan, nor its active metabolite is excreted from the body by hemodialysis.

Interaction:

May be administered in conjunction with other antihypertensive agents.

Clinically significant interaction of losargan with such drugs as hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin, not noted.

As with other agents that block the formation of angiotensin II and its effects, the simultaneous use of potassium-sparing diuretics (eg, spironolactone, griamterene, amiloride, eplerenone) or potassium boosters (eg heparin), potassium supplements and salts containing potassium, can lead to an increase in the potassium content in the blood plasma (see section "Special instructions").

As with the use of other agents that affect the excretion of sodium, treatment with losartan may be accompanied by a decrease in sodium excretion and an increase in plasma concentrationlithium, therefore, with simultaneous treatment with lithium preparations should monitor the plasma concentration of lithium.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2), can reduce the effect of diuretics or other antihypertensives. Therefore, the antihypertensive effect of angiotensin II receptor antagonists or ACE inhibitors may be weakened when used simultaneously with NSAIDs, including selective COX-2 inhibitors.

In some patients with impaired renal function who have been treated with NSAIDs, concomitant administration of angiotensin II antagonists can cause further impairment of kidney function, acute renal failure, hypernatremia, especially in patients with initial renal impairment, in patients with reduced BCC (or taking diuretics) , in patients with age-related renal function (older than 65 years). Usually, this effect is reversible.

Other antihypertensives can increase the severity of antihypertensive action of lozargan. Simultaneous use of drugs (eg, tricyclic antidepressants, neuroleptics, baclofen, amifostine),which reduce blood pressure as a major or side effect, may increase the risk of developing arterial hypotension.

Double blockade of RAAS with the use of angiotensin II receptor antagonists, ACE inhibitors or aliskiren is associated with an increased risk of arterial hypotension, syncope, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy. It is necessary to carefully monitor blood pressure, kidney function and water-electrolyte balance in patients taking losartan and other drugs that affect RAAS. Losartan It is not recommended to apply simultaneously with aliskiren or aliskiren-containing drugs in patients with diabetes mellitus. It is necessary to avoid simultaneous application of the drug Losartan and aliskiren in patients with renal insufficiency (glomerular filtration rate less than 60 ml / min / 1.73 m²).

Because the losartan predominantly metabolized with the participation of the CYP2C9 isoenzyme, potential interactions are possible with inducers and inhibitors of the CYP2C9 isoenzyme. Thus, in the presence of the inhibitor of the isoenzyme CYP2C9 fluconazole AUC losartan increases by 70%, while the AUC of its active metabolite decreases by 40-50%.With simultaneous administration of phenobarbital AUC losartan, as well as its active metabolite, increases by 20% (not clinically significant). Rifampicin leads to a decrease in AUC of lozaratan by 30%, active metabolite by 40%.

Fluvastatin, a weak inhibitor of the isoenzyme CYP2C9, does not change the pharmacokinetic parameters of losartan or its metabolite.

Cimetidine leads to an increase in AUC of losartan by 18% and does not affect the AUC of the active metabolite.

Ketoconazole, an inhibitor of the isoenzyme CYP3A4, does not affect the biotransformation of losartan. but erythromycin, which also inhibits the isoenzyme CYP3A4, increases the AUC of losartan by 30% (not clinically significant).

In case you are assigned losartan, and you take other medications, talk to your doctor about it.

Special instructions:

Allergic reactions

In patients who took losartan, anaphylactic reactions, an angioneurotic edema involving the larynx and pharynx, causing airway obstruction and / or edema of the face, lips, throat and / or tongue were rarely observed. Some of these patients had a history of angina stroke with other medications, including ACE inhibitors.Therefore, when prescribing a drug for patients with angioedema, a history of extreme caution should be followed. Angioedema occurs more often in patients of the Negroid race.

Arterial hypotension and disturbance of water-electrolyte balance or decrease in BCC

In patients with reduced BCC (for example, those receiving treatment with diuretics in high doses, with a diet with restriction of table salt, diarrhea, vomiting), symptomatic arterial hypotension may occur. Correction of such conditions should be performed prior to the appointment of losartan or to begin treatment with the use of the drug in a lower dose (see section "Method of administration and dose").

Violation of the water-electrolyte balance is characteristic of patients with renal insufficiency with type 2 diabetes mellitus or without diabetes mellitus, therefore, when prescribing a drug in this category of patients, special care should be taken in connection with the risk of hyperkalemia (see "Side effect", subsection " From the side of laboratory indicators ").

During the period of treatment, the potassium content in the blood plasma should be regularly monitored, especially in elderly patients, with renal dysfunction.During treatment with losartan, patients should not take potassium supplements or substitutes for edible salt containing potassium, without first consulting the physician.

Aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy

Like all drugs that have a vasodilating effect, angiotensin II receptor antagonists should be administered with caution to patients with aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy.

Ischemic heart disease and cerebrovascular disease

Like all drugs with a vasodilating effect, angiotensin II receptor antagonists should be administered with caution to patients with coronary heart disease or cerebrovascular disease, as excessive reduction in blood pressure in this group of patients can lead to myocardial infarction or stroke.

CHF

As with other drugs that have an effect on the ARAC, patients with CHF and with or without disturbed renal function have a risk of developing severe hypotension or acute renal failure.

There is insufficient experience with losartan in patients with heart failure and concomitant severe renal failure, in patients with severe heart failure (NYHA functional class IV IV), as well as in patients with heart failure and symptomatic life-threatening arrhythmias. therefore losartan should be administered with caution to patients in these groups.

Primary hyperaldosteronism

In patients with primary hyperaldosteronism, as a rule, there is no positive response to therapy with antihypertensive drugs that act by inhibiting RAAS, so the use of losartan is not recommended in this group of patients.

Impaired liver function

Data from pharmacokinetic studies indicate that the concentration of losartan in the blood plasma in patients with cirrhosis increases significantly, so patients with a history of liver disease should use the drug at a lower dose (see section "Method of administration and dose").

Impaired renal function

Due to inhibition of RAAS in some predisposed patients, changes in renal function were observed,including the development of renal failure. These changes may occur after discontinuation of treatment.

Some drugs that affect RAAS can increase the concentration of urea in the blood and serum creatinine in patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney. Changes in kidney function can be reversible after therapy. During the treatment period it is necessary to regularly monitor the concentration of creatinine in the blood plasma at regular intervals.

Elderly patients

Clinical studies have not revealed any difference in the safety and efficacy of losartan in elderly patients (over 65 years of age).

Race

Like other angiotensin II receptor antagonists, the drug Losartan may be insufficiently effective in lowering blood pressure in patients with low renin activity of blood plasma (in particular, in patients of the Negroid race compared with patients of other races).

Children and teens

Efficacy and safety of the drug Losartan in children and adolescents under the age of 18 years are not established.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and speed of the psychomotor reaction (possibly dizziness, especially at the beginning of therapy or with increasing doses, as well as in patients taking diuretic medicines and switched to drug therapy Losartan).

Form release / dosage:Film-coated tablets, 12.5 mg, 25 mg, 50 mg and 100 mg.

Packaging:

10, 15, 20 or 30 tablets in a planar cell packaging made of a polyvinylchloride film and aluminum foil.

30 or 60 tablets in a can of high-density polyethylene.

2, 3 or 6 contour cell packs of 10 tablets, 2, 4 or 6 contiguous cell packs of 15 tablets, 1 or 3 contour packs of 20 tablets each. 1, 2 or 3 contourcell packs of 30 tablets or one pot together with instructions for use in a pack of cardboard.

Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002443

Date of registration:29.04.2014 / 26.08.2015

Expiration Date:29.04.2019

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp04.04.2018

Illustrated instructions

Instructions

Losartan (Losartan)